Restrictive package for expandable or shape memory medical devices and method of preventing premature change of same

• US 5,765,682 A
• Filed: 06/24/1996
• Issued: 06/16/1998
• Est. Priority Date: 10/13/1994
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Menlo Care, Inc. (Johnson & Johnson)
• Inventors: Bladel, Kevin Van, Bley, Bob
• Primary Examiner(s): FIDEI, DAVID
• Application Number:
  US08/669,579
• Time in Patent Office: 722 Days
• Field of Search: 206/363, 206/364, 206/365, 206/438, 206/440, 206/497, 206/542.8, 206/528, 206/529, 206/571, 606/108, 604/171, 604/264, 604/281, 604/358, 383/207, 383/208, 383/209, 609/11, 609/12, 609/904
• US Class Current: 206/363
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30

Abstract

A package for a medical device made of an expandable or shape memory material is disclosed. The package is a sheath which surrounds and contains the medical device, and is of sufficient strength that upon exposure to conditions which would cause the medical device to expand or change its shape it is restrained from such shape change or expansion. The package has a tear-away or peel-away feature which provides easy access to the medical device when needed.

Claims

1. An assembly including a medical device and a package therefor, wherein said medical device is one of a catheter and a stent device, the medical device being shaped to have a continuous passage therethrough and made of a shape memory material or an expanding material which changes shape or expands, respectively, when exposed to a predetermined condition, said predetermined condition comprising exposure to an elevated temperature or a liquid, wherein said package comprises a sheath disposed around said medical device, said sheath comprising material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, wherein said sheath is removed before said medical device is placed in a body cavity.

2. The assembly of claim 1 wherein said sheath further comprises a line of weakened material disposed along its length whereby upon applying a force to said line of weakened material, said sheath is opened to expose said medical device for access thereto.

3. The assembly of claim 1 wherein said sheath further comprises a string embedded therein along the length of said sheath, whereby pulling said string causes a rupture in the sheath to expose said medical device for access thereto.

4. The assembly of claim 1 wherein said sheath further comprises a hole along its length with a patch covering said hole removably adhered thereto.

5. The assembly of claim 1 wherein said sheath is tightly constricting said medical device.

6. The assembly of claim 1 wherein said sheath surrounds said medical device with some clearance.

7. The assembly of claim 1 wherein said medical device comprises an irregularly shaped portion, and said sheath further comprises a window aligned with said irregularly shaped portion, wherebe said irregularly shaped portion extends through said window.

8. The assembly of claim 1 wherein said sheath is made of a material which has a deflection temperature of above about 65°

C. at 264 pounds per square inch.

9. The assembly of claim 1 wherein said sheath is made of a material selected from the group consisting of polyvinyl chloride, polyesters, polypropylene, polyamide, aliphatic polyesters, high density polyethylene, ethylene copolymers, polyurethane, acrylonitrile butadiene styrene, ABS, nylon, and fluoropolymers.

10. The assembly of claim 1 wherein said material is a dissolvable material.

11. The assembly of claim 10 wherein said dissolvable material is a hydrophilic material selected from the group consisting of polyethethylene oxide, polyvinyl pyrrolidone and polyvinyl alcohol.

12. A package for a metallic medical device, said medical device being made of a shape memory material or an expanding material which changes shape or expands respectively when exposed to a predetermined condition, said predetermined condition comprising exposure to an elevated temperature, said package comprising a sheath enclosing the medical device, said sheath comprising a material that prevents expansion or a change in shape of the medical device upon exposure of said medical device and sheath assembly to said predetermined condition, said sheath further comprising a tear-away means of opening for providing access to said medical device disposed therein, wherein said sheath is removed before said medical device is placed in a body cavity.

13. The package of claim 12 wherein said sheath further comprises a line of weakened material disposed along its length whereby upon applying a force to said line of weakened material, said sheath is opened to expose said medical device for access thereto.

14. The package of claim 12 wherein said sheath further comprises a string embedded therein along the length of said sheath, whereby pulling said string causes a rupture in the sheath to expose said medical device for access thereto.

15. The package of claim 12 wherein said sheath further comprises a hole along its length with a patch covering said hole removably adhered thereto.

16. The package of claim 12 wherein said sheath is tightly constricting said medical device.

17. The package of claim 12 wherein said sheath is made of a material which has a deflection temperature of above about 65°

C. at 264 pounds per square inch.

18. An assembly including a medical device and a package therefor, wherein said medical device is a communicative device and is made of a shape memory material or an expanding material which changes shape or expands respectively when exposed to a predetermined condition, wherein said medical device has a first configuration having a first length and a first dimension and a second configuration having a second length and a second dimension, said second length being longer than said first length, said second diameter, being smaller than said first diameter, wherein said package comprises a sheath disposed around said medical device, said sheath comprising a material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, wherein said sheath holds said medical device in said second configuration, and wherein said sheath is removed before said medical device is placed in a body cavity.

19. The assembly of claim 18 wherein said sheath further comprises a line of weakened material disposed along its length whereby upon applying a force to said line of weakened material, said sheath is opened to expose said medical device for access thereto.

20. The assembly of claim 18 wherein said sheath is tightly constricting said medical device.

21. The assembly of claim 18 wherein said sheath surrounds said medical device with some clearance.

22. The assembly of claim 18 wherein said sheath is made of a material which has a deflection temperature of above about 65°

C. at 264 pounds per square inch.

23. The assembly of claim 18 wherein said sheath is made of a material selected from the group consisting of polyvinyl chloride, polyesters, polypropylene, polyamide, aliphatic polyesters, high density polyethylene, ethylene copolymers, polyurethane, acrylonitrile butadiene styrene, ABS, nylon, and fluoropolymers.

24. A package for a medical device, said medical device is a communicative device being made of a shape memory material or an expanding material which changes shape or expands, respectively, when exposed to a predetermined condition, wherein said medical device has a first configuration having a first length and a first dimension and a second configuration having a second length and a second dimension, said second length being longer than said first length, said second dimension being smaller than said first dimension, said package comprising a sheath enclosing said medical device, said sheath comprising a material that prevents expansion or a change in shape of said medical device upon exposure of said medical device and sheath assembly to said predetermined condition, said sheath further comprising a tear-away means of opening for providing access to said medical device disposed therein, wherein said sheath holds said medical device in said second configuration and wherein said sheath is removed before said medical device is placed in a body cavity.

25. The package of claim 24 wherein said sheath further comprises a line of weakened material disposed along its length whereby upon applying a force to said line of weakened material, said sheath is opened to expose said medical device for access thereto.

26. The package of claim 24 wherein said sheath is tightly constricting said medical device.

27. The package of claim 24 wherein said sheath is made of a material which has a deflection temperature of above about 65°

C. at 264 pounds per square inch.